FDA 510(k) Application Details - K230502

Device Classification Name	Device, Inflation, Middle Ear   More FDA Info for this Device
510(K) Number	K230502
Device Name	Device, Inflation, Middle Ear
Applicant	Ningbo Albert Novosino Co., Ltd. No. 28 Yunshan Middle Road, Sanqishi town Yuyao 315412 CN Other 510(k) Applications for this Company
Contact	Victor Zhou Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MJV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2023
Decision Date	06/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review